QAB149 (indacaterol), an investigational bronchodilator from Novartis, East Hanover, NJ, met the primary efficacy endpoints of improved lung function compared to placebo at 12 weeks in three pivotal phase III studies in patients with chronic obstructive pulmonary disease (COPD). QAB149 also demonstrated clinically relevant lung function improvements within 5 minutes of the first dose, lasting for 24 hours in patients with COPD.
The data are the first from the phase III INVOLVE, INHANCE, and INLIGHT-1 trials, three multinational, multicenter, randomized, double blind, placebo-controlled studies comprising more than 3,800 patients with moderate-to-severe COPD.
"Current management of COPD focuses on the use of bronchodilators to optimize lung function," said Professor Stephen I. Rennard, MD, from the University of Nebraska Medical Center in an announcement from Novartis. "As presented at the ATS meeting, QAB149 is a long-acting beta-agonist bronchodilator given once daily that significantly improved both airflow and clinical outcomes. The ability to provide bronchodilation on a once-daily basis will be an important addition to the current therapeutic armamentarium in COPD."
In the 6-month INHANCE trial, QAB149 150 µg and 300 µg doses significantly improved lung function at 12 weeks compared to placebo. Statistically significant improvements were observed compared to placebo after 1 day, at the 12-week primary endpoint, and at 26 weeks.
During the 1-year INVOLVE trial QAB149 improved symptom control, nights free of awakening, and days able to perform usual activities over placebo.
In clinical studies, the most commonly reported adverse reactions with QAB149 were nasopharyngitis, upper respiratory tract infection, cough, and headache. QAB149 is currently undergoing regulatory review in the European Union and the United States.
The QAB149 data was presented at the [removed]American Thoracic Society’s 2009 International Conference[/removed] in San Diego.